MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Model Number 61000

Device Problems Use of Device Problem (1670); Defective Device (2588)

Patient Problem Hypovolemia (2243)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer initially contacted terumo bct for concern about the quality of service being performed on the machine by the biomeds.Per the customer, there was an incident occured during a procedure and caused their manager to be concerned if the machine is being maintained correctly.Per the customer, no further information about the incident was available at that time and this incident was reported at the time of the event by the operators.The machine is not covered by terumo bct service contract and, therefore, the customer's biomed perform the service and preventative maintenance (pm's) for the reported machine.One year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.Investigation is in process.A follow-up report will be provided.Mw5083581.

Event Description

The customer reported on a medwatch form that a patient had significant blood loss due to equipment malfunction during a plasmapheresis procedure.It was reported on the medwatch that it was believed it was possibly due to broken line inside machine centrifuge.The patient's fibrinogen level dropped from 170/dl(low) to 72 mg/dl( critical level) requiring transfusion offfp and medication to prevent historical life threatening allergic response to plasma.The customer chose not to include patient identifying information in the medwatch report.Follow-up with the customer multiple times regarding the incident details, procedural details and patient information/outcome was performed but resulted in no information as they have chosen to not disclose further information to terumo bct.

Manufacturer Narrative

This report is being filed to provide in investigation: per terumo bct's medical review, the device did not cause or contribute tothe reported event.According to customer, the patient also received medication to preventhistorical life-threatening allergic response to plasma.The comment about the use ofmedication to prevent allergic response when ffp was infused to address the decrease inpatient fibrinogen suggests ffp was not being used as the replacement solution during theprocedure.The use of albumin or saline/albumin replacement solution during a tpe procedureresults in decreases in circulating fibrinogen concentration.The expected decrease in fibrinogenconcentration after a one plasma volume exchange is 63%.The described decrease infibrinogen concentration from 170 mg/dl to 72 mg/dl is within the expected range for tpeprocedures carried to near completion.The review concluded that a blood loss of >35% dueto a leak would not have been possible for this incident based on the extracorporeal volume(ecv) of the disposable set.The results of this assessment indicate that the risk level is lowand/or mitigated to the point of no further action being required.There was no on-site service involved with the reported condition by terumo bct.Thecustomer stated that davita performed the procedures at his facility.Based on the information provided by the customer, they attributed the decrease in fibrinogento the blood loss as a result of the leak in the centrifuge.The malfunction described as"possibly due to broken line inside machine centrifuge" would have resulted in an alarmtriggered by the machine leak detector located inside the centrifuge basin, which wouldprevent continuation of the procedure, and would be unlikely to result in a large volume bloodloss.The extracorporeal volume of an exchange set is approximately 197 ml.Based on thisvolume, a loss of blood would not, in itself, result in a clinically significant decrease in circulatingfibrinogen concentration, but in a decrease in circulating blood volume.Since attempts to reach the customer for further information were unsuccessful, retraining wasnot offered or provided for this incident.The customer did not provide the lot number pertaining to this event, therefore a devicehistory record (dhr) search could not be conducted for this specific incident.All lots mustmeet acceptance criteria before release.The optia operator's manual provides a prediction for the percentage of substance removedfrom the patient's plasma.The percentage that is removed assumes that there is noequilibration with the extravascular compartment and that the patient¿s plasma volume remainsconstant during the procedure.According to table 7-3, which shows how the number ofplasma volumes exchanged correlates to the removal of a hypothetical substance from thepatient¿s plasma, a plasma volume exchange of 1.0 results in a 63% removal of substance.Root cause: based on the customer's statements and the medical review findings, the rootcause of the decrease in fibrinogen levels was due to the use of saline/albumin as replacementfluid.Based on the clinical findings, the specific root cause of the leak could not be determined.Possible causes include, but are not limited to:- incorrect loading of the disposable set in the filler channel.- incomplete seating of the centrifuge collar (hex) in the holder such as the latch pin notengaging.- incomplete seating of the loop bearing into either bearing holder.- an unidentified supplier or manufacturing component defect of the disposable set.Corrected investigation: removal of udi number and device manufacture date providedin the intial mdr as a result of the investigation being conducted under the disposables catalogwhich has no udi associated with it on the fda website and as no lot number was provided,the manufacture date is not available.

Event Description

The spectra optia exchange set is not available for return because it was discarded by thecustomer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8404329
• MDR Text Key: 138272655
• Report Number: 1722028-2019-00048
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention